510(k) · Cleared
ClearedShockwave Medical Peripheral Intravascular Lithotripsy (IVL) System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shockwave Medical, Inc. · PPN Percutaneous Catheter, Ultrasound
Cleared on Apr 25, 2022 as substantially equivalent to K203365 (Shockwave Medical, Inc., 2021) after a 17-day review. Its family tree reaches back 17 generations to 1990.
- Decided
- Apr 25, 2022
- Review
- 17 days
- Class
- Class II
- Product code
- PPN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K904788 (1990). 74 ancestors in all. No later device cites it as a predicate yet.
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 13 generations between
- 3 generations backK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- 2 generations backK180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter…Shockwave Medical, Inc. · 2018
- 1 generation backK203365 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave…Shockwave Medical, Inc. · 2021
- This deviceK221041 Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2022
Show all 17 generations
- Root · 17 generations backK904788 Mewissen CatheterBoston Scientific Corp · 1990
- 16 generations backK974067 Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc. · 1998 · Recalled
- 15 generations backK981417 Squirt Fluid Delivery SystemMerit Medical Systems, Inc. · 1998
- 14 generations backK013635 Trellis Infusion System (10CM Infusion Length); Trellis Infusion…Bacchus Vascular, Inc. · 2002
- 13 generations backK021958 Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion…Bacchus Vascular, Inc. · 2002 · Recalled
- 12 generations backK023514 Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM…Bacchus Vascular, Inc. · 2002 · Recalled
- 11 generations backK030637 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 10 generations backK033214 Ekos Peripheral Infusion SystemEkos Corp. · 2003
- 9 generations backK041629 Lysus Infusion SystemEkos Corp. · 2004
- 8 generations backK042456 Lysus Infusion SystemEkos Corp. · 2004 · Recalled
- 7 generations backK051319 Lysus Infusion SystemEkos Corp. · 2005
- 6 generations backK052071 Lysus Infusion SystemEkos Corp. · 2005
- 5 generations backK060422 Lysus Infusion SystemEkos Corp. · 2006 · Recalled
- 4 generations backK161384 Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty…Shockwave Medical, Inc. · 2016
- 3 generations backK163306 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty…Shockwave Medical, Inc. · 2016
- 2 generations backK180958 Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter…Shockwave Medical, Inc. · 2018
- 1 generation backK203365 Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave…Shockwave Medical, Inc. · 2021
- This deviceK221041 Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K904788 | Mewissen Catheter | Boston Scientific Corp | 1990 | — |
| −16 | K974067 | Fountain Infusion Catheter and Occluding Guide Wire | Merit Medical Systems, Inc. | 1998 | 23 |
| −15 | K981417 | Squirt Fluid Delivery System | Merit Medical Systems, Inc. | 1998 | — |
| −14 | K013635 | Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM… | Bacchus Vascular, Inc. | 2002 | — |
| −13 | K021958 | Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM… | Bacchus Vascular, Inc. | 2002 | 1 |
| −12 | K023514 | Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion… | Bacchus Vascular, Inc. | 2002 | 1 |
| −11 | K030637 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −10 | K033214 | Ekos Peripheral Infusion System | Ekos Corp. | 2003 | — |
| −9 | K041629 | Lysus Infusion System | Ekos Corp. | 2004 | — |
| −8 | K042456 | Lysus Infusion System | Ekos Corp. | 2004 | 3 |
| −7 | K051319 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −6 | K052071 | Lysus Infusion System | Ekos Corp. | 2005 | — |
| −5 | K060422 | Lysus Infusion System | Ekos Corp. | 2006 | 1 |
| −4 | K161384 | Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and… | Shockwave Medical, Inc. | 2016 | — |
| −3 | K163306 | Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And… | Shockwave Medical, Inc. | 2016 | — |
| −2 | K180958 | Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter… | Shockwave Medical, Inc. | 2018 | — |
| −1 | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+… | Shockwave Medical, Inc. | 2021 | — |
| 0 (this device) | K221041 | Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System | Shockwave Medical, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 4 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 5 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PPN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new PPN device
- #1 K262201 Shockwave Intravascular Lithotripsy (IVL)…score 16.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203365 | Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Summary page 4…fication Name: Percutaneous catheter Product Code: PPN Predicate Device The predicate device is the Shockwave Medical Intravascular Lithotripsy System, K203365, cleared by FDA on April 22, 2021. Indications for Use / Intended Use The Shockwave Medical IVL System is intended for lithotrip… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- 15 of the 74 ancestors have a recall of any class.
How does its category compare?
All PPN devicesPPN Percutaneous Catheter, Ultrasound: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · PPN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PPN
56in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PPN
No recall names PPN since 2007.
Adverse event reports per year · PPN
43in 2025
MAUDE reports naming product code PPN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 2 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 2 | — | 0 | 3 |
| 2019 | 1 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 18 |
| 2022 | 2 | — | 0 | 35 |
| 2023 | 0 | — | 0 | 30 |
| 2024 | 3 | 56 | 0 | 45 |
| 2025 | 1 | — | 0 | 43 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Shockwave Medical IVL System is intended for lithotripsy-enhanced balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. Not for use in the coronary or cerebral vasculature.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K221041 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221041: Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221041
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026